Quetiapine Fumarate
- Product NDC
- 68788-8823
- 11-digit product format
- 687888823
- Labeler code
- 68788
- Product ID
- 68788-8823_69275af7-1469-4405-a98e-e8b0f8d42dd9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA201504
- Marketing category
- ANDA
- Marketing start
- 2025-02-10
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Quetiapine Fumarate
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| QUETIAPINE FUMARATE | 25 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 312744 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 2S3PL1B6UJ | QUETIAPINE FUMARATE | 111974-72-2 | QUETIAPINE FUMARATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8823-1 | 68788882301 | 100 TABLET in 1 BOTTLE (68788-8823-1) | 100 tablet | 2025-02-10 | No | No | Historical |
| 68788-8823-3 | 68788882303 | 30 TABLET in 1 BOTTLE (68788-8823-3) | 30 tablet | 2025-02-10 | No | No | Historical |
| 68788-8823-6 | 68788882306 | 60 TABLET in 1 BOTTLE (68788-8823-6) | 60 tablet | 2025-02-10 | No | No | Historical |
| 68788-8823-8 | 68788882308 | 120 TABLET in 1 BOTTLE (68788-8823-8) | 120 tablet | 2025-02-10 | No | No | Historical |
| 68788-8823-9 | 68788882309 | 90 TABLET in 1 BOTTLE (68788-8823-9) | 90 tablet | 2025-02-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Quetiapine Fumarate | Preferred Pharmaceuticals Inc. | 2025-02-10 | HUMAN PRESCRIPTION DRUG LABEL | 1 |